Sr. Specialist QA- 35711

CIS International LLC; Juncos (PR); On-site; USD 140,000 - 210,000; Full time

Job summary

CIS International LLC is seeking a senior QA technical specialist to support Amgen's Quality Assurance program in Juncos, Puerto Rico. You will review and approve MPs, and lead investigations to ensure product quality across manufacturing and distribution.

This onsite, full-time role requires advanced degrees and extensive experience in validation, GMP compliance, and regulatory interactions. You will own site quality procedures and act as QA on incident triage and NPI teams.

Qualifications

• Doctorate or Masters with extensive QA/validation background required.
• Bachelor level with significant related experience also considered.

Responsibilities

• Review and approve MPs and environmental characterization reports.
• Lead investigations and own site quality program procedures.

Skills

Project management

Cross-functional leadership

Regulatory interaction

Data analysis

Process validation

Education

Doctorate + 2 years of directly related experience

Masters + 4 years of directly related experience

Bachelors + 6 years of directly related experience

Associates + 10 years of directly related experience

High school/GED + 12 years of directly related experience

Job description

SUMMARY:

In support of Amgen's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS:

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

EDUCATION:

• Doctorate + 2 years of directly related experience.
• Masters + 4 years of directly related experience.
• Bachelors + 6 years of directly related experience.
• Associates + 10 years of directly related experience.
• High school/GED + 12 years of directly related experience.

PREFERRED QUALIFICATIONS:

• Facilities and Utilities Commissioning and Qualification
• Computer System Validation
• Equipment validation
• Risk Assessments
• KNEAT,CDOCS, SCADA, TRACKWISE, MAXIMO
• Good Documentation Practices, Data Integrity
• Change Controls
• Standard Operation Procedure
• Syringe/Vials Inspection Process
• Documents revision and approval
• Strong knowledge in Decision Making Techniques
• Risk Management

SKILLS:

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing, and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
• Demonstrated ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Amgen Values/Leadership Practices.

WORK METHODOLOGY:

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 11 months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Expected hiring date: October 2026